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Clinical efficacy of once-daily micronized purified flavonoid fraction 1000 mg tablet in patients with symptomatic chronic venous disease.
Curr Med Res Opin. 2019 03; 35(3):553-557.CM

Abstract

AIM

To investigate the clinical efficacy of micronized purified flavonoid fraction (MPFF) 1000 mg given as a single 1000 mg tablet once daily in patients suffering from chronic venous disease (CVD) vs MPFF 500 mg twice daily.

METHODS

In an international, randomized, double-blind, parallel-group study, patients classified C0s to C4 according to Clinical Etiological Anatomic Pathophysiologic [CEAP] classification and with leg pain graded as superior to 4 cm on a 10-cm visual analog scale (VAS), were treated for 8 weeks with either MPFF 1000 mg once daily or MPFF 500 mg twice daily. The present post-hoc analysis focuses on the effect of treatment over time in patients randomized to the MPFF 1000 mg group. Leg pain was assessed at each follow-up visit by VAS. VAS scores over time were compared between each visit using paired Student t-tests.

RESULTS

In total, 87 patients out of 174 were randomized to the MPFF 1000 mg group. Mean age ± SD was 49.1 ± 12.2 years, most of the patients were female (81.6%), the main CEAP classes of the most affected leg were C1 (20.7%), C2 (39.1%), C3 (33.33%), and the mean duration of CVD was 14.6 ± 10.9 years. Patients with previous CVD treatment represent 27.6% of the patients. A MPFF 1000 mg tablet once daily was associated with a significant and continuous reduction in leg pain throughout the treatment period: -1.54 cm (±1.45) from baseline to week 2 (p < .01), -1.11 cm (±1.06) from week 2 to week 4 (p < .01), -1.57 cm (±1.05) from week 4 to week 8 (p < .01).

CONCLUSIONS

The new MPFF 1000 mg dose regimen in once daily tablets was associated with a rapid and continuous reduction in leg pain throughout the 8-week treatment period.

Authors+Show Affiliations

a Russian Scientific Research Medical University named after N. I. Pirogova , Department of Faculty Surgery , Moscow , Russia.b Institute for Cardiovascular Diseases , Clinic for Vascular Surgery , Beograd , Serbia. c Serbian Academy for Science and Ars , Belgrad , Serbia. d University of Belgrad , Serbia.e Institut de Recherches Servier Suresnes , Suresnes , France.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29992831

Citation

Kirienko, A, et al. "Clinical Efficacy of Once-daily Micronized Purified Flavonoid Fraction 1000 Mg Tablet in Patients With Symptomatic Chronic Venous Disease." Current Medical Research and Opinion, vol. 35, no. 3, 2019, pp. 553-557.
Kirienko A, Radak D, Maggioli A. Clinical efficacy of once-daily micronized purified flavonoid fraction 1000 mg tablet in patients with symptomatic chronic venous disease. Curr Med Res Opin. 2019;35(3):553-557.
Kirienko, A., Radak, D., & Maggioli, A. (2019). Clinical efficacy of once-daily micronized purified flavonoid fraction 1000 mg tablet in patients with symptomatic chronic venous disease. Current Medical Research and Opinion, 35(3), 553-557. https://doi.org/10.1080/03007995.2018.1499508
Kirienko A, Radak D, Maggioli A. Clinical Efficacy of Once-daily Micronized Purified Flavonoid Fraction 1000 Mg Tablet in Patients With Symptomatic Chronic Venous Disease. Curr Med Res Opin. 2019;35(3):553-557. PubMed PMID: 29992831.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical efficacy of once-daily micronized purified flavonoid fraction 1000 mg tablet in patients with symptomatic chronic venous disease. AU - Kirienko,A, AU - Radak,D, AU - Maggioli,A, Y1 - 2018/08/14/ PY - 2018/7/12/pubmed PY - 2018/7/12/medline PY - 2018/7/12/entrez KW - Chronic venous disease KW - Dose regimen KW - Leg pain KW - Micronized purified flavonoid fraction 1000 mg KW - Tablets KW - Visual analog scale SP - 553 EP - 557 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 35 IS - 3 N2 - AIM: To investigate the clinical efficacy of micronized purified flavonoid fraction (MPFF) 1000 mg given as a single 1000 mg tablet once daily in patients suffering from chronic venous disease (CVD) vs MPFF 500 mg twice daily. METHODS: In an international, randomized, double-blind, parallel-group study, patients classified C0s to C4 according to Clinical Etiological Anatomic Pathophysiologic [CEAP] classification and with leg pain graded as superior to 4 cm on a 10-cm visual analog scale (VAS), were treated for 8 weeks with either MPFF 1000 mg once daily or MPFF 500 mg twice daily. The present post-hoc analysis focuses on the effect of treatment over time in patients randomized to the MPFF 1000 mg group. Leg pain was assessed at each follow-up visit by VAS. VAS scores over time were compared between each visit using paired Student t-tests. RESULTS: In total, 87 patients out of 174 were randomized to the MPFF 1000 mg group. Mean age ± SD was 49.1 ± 12.2 years, most of the patients were female (81.6%), the main CEAP classes of the most affected leg were C1 (20.7%), C2 (39.1%), C3 (33.33%), and the mean duration of CVD was 14.6 ± 10.9 years. Patients with previous CVD treatment represent 27.6% of the patients. A MPFF 1000 mg tablet once daily was associated with a significant and continuous reduction in leg pain throughout the treatment period: -1.54 cm (±1.45) from baseline to week 2 (p < .01), -1.11 cm (±1.06) from week 2 to week 4 (p < .01), -1.57 cm (±1.05) from week 4 to week 8 (p < .01). CONCLUSIONS: The new MPFF 1000 mg dose regimen in once daily tablets was associated with a rapid and continuous reduction in leg pain throughout the 8-week treatment period. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/29992831/Clinical_efficacy_of_once_daily_micronized_purified_flavonoid_fraction_1000_mg_tablet_in_patients_with_symptomatic_chronic_venous_disease_ L2 - http://www.tandfonline.com/doi/full/10.1080/03007995.2018.1499508 DB - PRIME DP - Unbound Medicine ER -